Recall Z-3168-2024 · KPR System, X-Ray, Stationary
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva
| Date | Sep 18, 2024 (initiated Aug 22, 2024) |
| Status | Open, Classified |
| Reason | Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury. |
| Root cause | Device Design |
| Action | Philips Issued URGENT Medical Device Correction Letter (Philips Reference # 2023-IGT-BST-006) on 8/22/24. Letter states reason for recall, health risk and action to take: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the instructions below. b. Avoid that operators or bystanders stand underneath the Cable Hose Carriers, especially when moving or turning the system monitor. c. Avoid having the patient located underneath the Cable Hose Carriers (e.g., during transport). d. If you notice loose or broken bolts and/or broken plastic parts of the |
| Quantity | 109 units |
| Distribution | Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050151 | MULTIDIAGNOST ELEVA Philips Medical Systems North America, Inc., Feb 9, 2005 |